FDA Authorizes COVID-19 Shots for Infants and Preschoolers

U.S. regulators approved the first COVID-19 shot for babies and toddlers Friday, opening the door for next week’s vaccinations.

The Food and Drug Administration’s action follows its advisory panel’s unanimous recommendation for the shots from Moderna and Pfizer. That means U.S. kids under 5—roughly 18 million youngsters—are eligible for the shots, about 1 1/2 years after the vaccines first became available in the U.S. for adults, who have been hit the hardest during the pandemic.

The FDA also authorized Moderna’s vaccine for school-aged children and teens. Pfizer’s shots had previously been the only ones available for those ages.

There’s one step left: The Centers for Disease Control and Prevention recommends how to use vaccines and its vaccine advisers are set to discuss the shots for the youngest kids Friday and vote on Saturday. The final approval would be given by Dr. Rochelle Walensky, Director of the CDC.

At a Senate hearing Thursday, Walensky said her staff was working over the Juneteenth federal holiday weekend “because we understand the urgency of this for American parents.”

Her statement stated that COVID-19 has resulted in more pediatric deaths than the average flu season.

“So I actually think we need to protect young children, as well as protect everyone with the vaccine and especially protect elders,” she said.

The Biden administration was preparing for the rollout of the vaccines since weeks. States, tribes, communities health centers and pharmacies have preordered millions. FDA’s emergency use authorization allows manufacturers to begin shipping vaccine across the country. You could start vaccinating as early Monday as Tuesday.

Many parents are anxiously waiting to be able to safeguard their children.

While young children generally don’t get as sick from COVID-19 as older kids and adults, their hospitalizations surged during the Omicron wave and FDA’s advisers determined that benefits from vaccination outweighed the minimal risks. Moderna and Pfizer studies showed that side effects such as fatigue and fever were very rare.

Both brands share the same technology, but they have their own unique features.

Pfizer’s vaccine for kids younger than 5 is one-tenth of the adult dose. You will need three shots: The first two should be given within 3 weeks, and then the third at least 2 months later.

Moderna’s is two shots, each a quarter of its adult dose, given about four weeks apart for kids under 6.

Children as young at 6 months old can get the vaccines. Moderna plans to next study vaccines for infants as young as 3 months old. Pfizer does not have plans to offer shots to infants under 5. China and a dozen other countries have already begun to vaccinate children below 5.

Professor Beth Ebel of Pediatrics, University of Washington, Seattle said that the small-sized vaccines are especially welcome by parents in America with daycare children. In these cases, parents can lose their jobs and financial stress due to outbreaks.

“A lot of people are going to be happy and a lot of grandparents are going to be happy, too, because we’ve missed those babies who grew up when you weren’t able to see them,” Ebel said.


AP Medical writers Carla K. Johnson, Laura Ungar, and Carla K. Johnson all contributed.

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